DETAILED ACTION
This office action is in response to applicant’s filing dated August 20, 2025.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 30-49 are pending in the instant application. Acknowledgement is made of Applicant's remarks and amendments filed August 20, 2025. Acknowledgement is made of Applicant's cancelation of claims 1-29; and addition of new claims 30-49.
Election/Restrictions
Applicant’s election of Group I, drawn to a method of treating a coronavirus infection in a subject in need thereof comprising administering to said subject a therapeutically effective amount of a thiol-containing compound and a pharmaceutically acceptable carrier in the reply filed on August 20, 2025 is acknowledged. Applicant’s election of bucillamine as the thiol-containing compound species and no additional components in the reply filed on August 20, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 46 and 47 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 202, 2025.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 111 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Provisional Application No. 63/024,315, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. In a review of provisional application, disclosure of bucillamine and or post-acute COVID syndrome was not identified. Thus, the disclosure of the prior-filed application fails to provide adequate support for the instant claims.
The effective filing date of the instant claims is May 11, 2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on January 24, 2023; April 22, 2024; and July 18, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
The drawings are objected to because:
In Fig. 6B, it is difficult to decipher between the lines in the graph and which line corresponds to which drug in the legend.
In Fig. 6D, it is difficult to decipher between the lines in the graph and which line corresponds to which drug in the legend.
In Fig. 6I, it is difficult to decipher between the lines in the graph and which line corresponds to which drug in the legend.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112(b)
Indefinite
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 36 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 36 is directed to the use of any one of claims 4 to 15. Claims 4 to 15 are canceled. Thus, it is unclear what the metes and bounds of claim 36. The Examiner notes that claim 36 contains a method step and thus appears to be directed to a method. However, it is not clear what method is encompassed by the claims since the claims recite “The use…” with no specific method.
Claim Rejections - 35 USC § 112(a)
Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 37, 40-45, 48, and 49 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
The Written Description Guidelines for examination of patent applications indicates, "the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical characteristics and/or other chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show applicant was in possession of the claimed genus." (Federal register, Vol. 66, No. 4, pages 1099-1111, Friday January 5, 2001, see especially page 1106 column 3) and (see MPEP 2164).
Claims 37, 40-45, 48, and 49 are directed to a method of treating post-acute COVID syndrome or a coronavirus infection in a subject in need thereof comprising administering an effective amount of a thiol-containing compound. Thus, the claims encompass a method of treating post-acute COVID syndrome or a coronavirus infection comprising administering a genus of compounds which contain a thiol-containing compound. In a review of the specification, the specification defines a thiol-containing compound as a compound with at least one thiol (-SH) moiety. Thus, the claims encompass a broad scope of compound, any compound having a thiol (-SH). In a review of the specification, the specification discloses about 50 compounds that are thiol-containing compounds (see paragraphs [074-0077].
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated:
"To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966." Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated:
"A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus …") Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure, it is "not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence." MPEP § 2163. The MPEP does state that for a generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP § 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. Although the MPEP does not define what constitute a sufficient number of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad generic. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618.
In the instant case, the claims are drawn to a method of treating post-acute COVID syndrome or a coronavirus infection in a subject in need thereof comprising administering an effective amount of a thiol-containing compound. The claims are generic, broadly reciting a genus of “a thiol-containing compound”
As stated supra, the MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable that claims 37, 40-45, 48, and 49 are broad and generic, with respect to all possible compounds encompassed by the claims.
Applicant has failed to show that they were in possession of all the diverse compounds encompassed by thiol-containing compound. Applicant discloses a very narrow set of compounds encompassing a thiol moiety (see paragraphs [074-0077]), despite claiming any compound having a thiol moiety. The small set of compounds cannot be viewed as being reasonably representative of the genus in its claimed scope because no readily apparent combination of identifying characteristics is provided, other than the disclosure of a single moiety (-SH) and the disclosure of those specific species as examples of the claimed genus.
Given the broad scope of the claimed subject matter, Applicant has not provided sufficient written description that would allow the skilled in the art to recognize all the compounds claimed to be useful in the method of claim 30.
Claim Rejections - 35 USC § 112
Scope of Enablement
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 37-44 and 46-49 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating post-acute COVID syndrome, a coronavirus infection, or inflammation comprising administering bucillamine, amifostine, N-acetylcysteine, tiopronin, cysteamine, sodium-2-mercaptoethane sulfonate, or WR- 1065, does not reasonably provide enablement for a method for treating a post-acute COVID syndrome, a coronavirus infection, or inflammation comprising administering any thiol-containing compound. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. This is a scope of enablement rejection.
To be enabling, the specification of the patent application must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fd. Cir. 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated that:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996). As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is "undue", not "experimentation".
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 1986) at 547 the court recited eight factors:
1- the quantity of experimentation necessary,
2- the amount of direction or guidance provided,
3- the presence or absence of working examples,
4- the nature of the invention,
5- the state of the prior art,
6- the relative skill of those in the art,
7- the predictability of the art, and
8- the breadth of the claims
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
1. The nature of the invention, state and predictability of the art, and relative skill of those in the art
The invention relates to a method for treating any post-acute COVID syndrome or a coronavirus infection comprising administering any thiol-containing compound or a method of treating inflammation comprising administering any thiol-containing compound. Claim 48 further narrows an inflammation to those not mediated by bacteria or a single-stranded RNA virus. The instant specification defines "treating" as including preventing disease’s transmission or spread as well as cure or prevention of a disease (see [0046].
The relative skill of those in the art is high, generally that of a D.V.M. or Ph.D. The artisan using Applicant’s invention would generally be a veterinarian with a V.M.D. degree and several years of experience.
The factor is outweighed, however, by the unpredictable nature of the art. It is well established that “the scope of enablement varies with the degree of unpredictability of the factors involved” and physiological activity is considered to be an unpredictable factor. See In re Fisher, 166 USPQ 18, at 24 (In cases involving unpredictable factors, such as most chemical reactions and physiological activity, the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved); Nationwide Chemical Corporation, et. al. v. Wright, et. al., 192 USPQ 95 (one skilled in chemical and biological arts cannot always reasonably predict how different chemical compounds and elements might behave under varying circumstances); Ex parte Sudilovsky 21 USPQ2d 1702 (Applicant’s invention concerns pharmaceutical activity. Because there is no evidence of record of analogous activity for similar compounds, the art is relatively unpredictable); In re Wright 27 USPQ2d 1510 (the physiological activity of RNA viruses was sufficiently unpredictable that success in developing specific avian vaccine was uncertain). As illustrative of the state of the art, the examiner cites Lobo-Galo et al (Journal of Biomolecular Structure and Dynamics, 2020; 39(9):3419-3427 pp 1-9).
Lobo-Galo teaches the thiol-containing compounds DSF and captopril (Figure 1):
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Lobo-Galo teaches emergent novel SARS-CoV-2 is responsible for the current pandemic outbreak of severe acute respiratory syndrome with high mortality among the symptomatic population worldwide; given the absence of a current vaccine or specific antiviral treatment, it is urgent to search for FDA-approved drugs that can potentially inhibit essential viral enzymes (Abstract); in silico selective screening of some thiol-reacting FDA-approved drugs that bind to the main active site cavity of 3CLpro could be further evaluated by in vitro and in vivo experiments in specialized laboratories (page 2, right 2nd paragraph); from the docking experiments, it was observed that both disulfiram and captopril bind at the active site of the enzyme with relative proximity to the thiol group of Cys145 (page 3, right, last paragraph); both DSF and captopril bind at the active site of 3LCpro (6lu7), at the position where the N3 inhibitor was observed bound in the crystal structure; the models infer that both DSF and captopril occupy the same subsite as N3, and obstruct the function of the catalytic dyad Cys145 and His41; and consequently, we predict that binding of these two molecules, as well as the DSF metabolites, will result in competitive inhibition of the viral protease (page 4, left, 2nd paragraph). Lobo-Galo teaches the administration of a single dose of captopril provides pharmacological activity in a short time (10-30 min) at the cellular level; this is due to the fact that it is transported mainly by plasma proteins (albumin) and is absorbed between 60-75% of the total in the form of captopril-cysteine disulfide and the captopril disulfide dimer; these metabolites can undergo a reversible interconversion with a half-life of approximately two hours; although, the potential binding capacity of captopril over 3CLpro is shown here, with the current data we cannot suggest its clinical therapeutic use against COVID-19 (Table 2), since prolonged administration of this drug induces an overexpression of the angiotensin-II converting enzyme (ACE-2), the main receptor used by SARS-CoV-2 to enter human cells; thus, it could potentially increase the susceptibility to infection and exacerbate symptoms and medical complications (page 6).
Lobo-Galo teaches the pharmacokinetics studies of DSF indicate that a relatively small fraction of the compound is excreted in urine after 6h of administration (5-20%) and maintaining a half-life of 6 h in the plasma (page 4, left, last bridge paragraph). Lobo-Galo teaches DSF is used to facilitate the treatment of chronic alcoholism, as it targets the hepatocyte mitochondrial acetaldehyde dehydrogenase (ALDH-2), an enzyme to which the drug and its metabolites acts by blocking its catalytic cysteine; hence, it is clear that DSF and its metabolites can penetrate human cells; and consequently, have a high potential to block the proteolytic function of the 3CLpro, essential for SARS-CoV-2 replication; it is known that DSF and its metabolites not only block aldehyde dehydrogenase-2, as it has also been recognized as an inhibitor of other cysteine-dependent enzymes.
Thus, Lobo-Galo establishes that different thiol-containing compounds can have very different effects, targeting different enzymes. Lobo-Galo teaches despite having common function of blocking proteolytic function of 3CLpro, SARS-CoV-2mp could be blocked and inactivated by DSF and its thiol reactive derivative metabolites, while captopril induces overexpression of angiotensin-II converting enzyme (ACE-2), the main receptor used by SARS-CoV-2 to enter human cells, which could increase susceptibility to infection and exacerbate symptoms and medical complications. Thus, the art of producing thiol-containing compounds for the treatment of post-acute COVID syndrome, a coronavirus infection, or inflammation is extremely unpredictable.
2. The breadth of the claims
Claims 37-44 and 46-49 are very broad in terms of the compounds claimed to be useful for treating post-acute COVID syndrome, a coronavirus infection. The Examiner further notes that a search in the prior art for thiol (-SH) containing compounds resulted in over 3 million compound results.
3. The amount of direction or guidance provided and the presence or absence of working examples
The specification provides examples wherein bucillamine, amifostine, N-acetylcysteine, tiopronin, cysteamine, sodium-2-mercaptoethane sulfonate, or WR- 1065 inhibit SARS-CoV-2 virus infectivity in VeroE6 cells. However, the specification does not provide any data that shows that any thiol-containing compound is useful for treating post-acute COVID syndrome, a coronavirus infection, and/or inflammation, other than bucillamine, amifostine, N-acetylcysteine, tiopronin, cysteamine, sodium-2-mercaptoethane sulfonate, or WR- 1065.
4. The quantity of experimentation necessary
Because of the known unpredictability of the art (as discussed supra) and in the absence of experimental evidence commensurate in scope with the claims, the skilled artisan would not accept that any thiol-containing compound could be predictably used as treatment for post-acute COVID syndrome, a coronavirus infection, and/or inflammation other than bucillamine, amifostine, N-acetylcysteine, tiopronin, cysteamine, sodium-2-mercaptoethane sulfonate, or WR- 1065.
Determining if a particular thiol-containing compound will treat post-acute COVID syndrome, a coronavirus infection, and/or inflammation would require formulation into a dosage form, and subjecting into clinical trials or to testing in an assay known to correlate to clinical efficacy of such treatment. This is undue experimentation given the limited guidance and direction provided by Applicants.
Accordingly, the inventions of claims 37-44 and 46-49 do not comply with the scope of enablement requirement of 35 U.S.C 112, first paragraph, since to practice the claimed invention a person of ordinary skill in the art would have to engage in undue experimentation with no assurance of success.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 30, 32, 34, 36-41, 43-45, 48, and 49 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Chianelli et al (WO 2021/184115 A1, effective filing date March 19, 2020).
Regarding claims 30, 32, and 37-40, Chianelli teaches a method for the treatment of an infectious disease in a mammal comprising administering a therapeutically effective amount of bucillamine or a pharmaceutically acceptable salt or solvate thereof to a mammal in need thereof (claim 1); wherein the infections disease is coronavirus disease 2019. Coronavirus disease 2019 reads on a SARS-CoV-2 virus infection.
Regarding claims 34 and 41, Chianelli teaches the pharmaceutical compositions may be formulated for administration by any route, for example by the oral (including buccal or sublingual (page 5, 2nd paragraph).
Regarding claim 43, Chianelli teaches the pharmaceutical compositions can be formulated as powders (page 5, 2nd paragraph).
Regarding claims 44, 45, 48, and 49, Chianelli teaches reactive oxygen species (ROS) generation during influenza virus infection aggravate destructive inflammation and programmed death of epithelial cells (page 1, 1st paragraph); bucillamine provides protection against oxidative stress by donating thiol groups to GSH; this reactivates GSH and increases the amount available to remove reactive oxygen species, enhancing its endogenous antioxidant activity; and bucillamine can be used to treat infectious disease symptoms, such as influenza symptoms and coronavirus disease 2019 (COVID 19) symptoms, by reducing tissue damage from reactive oxygen species.
The prior art is silent regarding “treating inflammation in a lung.” However: “treating inflammation in a lung” will inevitably flow from the teachings of the prior art (see above rejection), since the same compound (bucillamine) is being administered to the same subjects (a subject suffering from COVID 19 infection/SARS-CoV-2 virus infection). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances.
In other words, even though the prior art is silent regarding “treating inflammation in a lung,” by practicing the method taught by the prior art: “the administration of bucillamine to a patient suffering from COVID 19 infection/SARS-CoV-2 virus infection,” one will also be “treating inflammation in a lung,” even though the prior art was not aware of it.
Apparently, Applicant has discovered a new property or advantage (“treating inflammation in a lung”) of the method taught by the prior art (“the administration of bucillamine to a patient suffering from COVID 19 infection/SARS-CoV-2 virus infection”).
MPEP 2112 I states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 31 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Chianelli et al (WO 2021/184115 A1, effective filing date March 19, 2020) as applied to claims 30, 32, 34, 36-41, 43-45, 48, and 49 above.
Chianelli teaches all the limitations of claim 31 (see above 102 rejection), except wherein the method is for treating post-acute COVID syndrome. However, the instant specification teaches the subject in need thereof has post-acute COVID syndrome (e.g., COVID long haul syndrome) and treatment is administered because the syndrome may be caused by persistent viral infection in the airways and lungs (see paragraph [0067]). Thus, a subject having persistent viral infection in the airways and lungs is construed to meet the limitation of a post-acute COVID syndrome.
Chianelli teaches the method of treatment is for preventing or reducing acute lung injury during an infection (page 2, last paragraph); bucillamine can be used to treat infectious disease symptoms, such as influenza symptoms and coronavirus disease 2019 (COVID 19) symptoms, by reducing tissue damage from reactive oxygen species (page 2, 2nd paragraph). Chianelli teaches patients with Mild-Moderate COVID-19 received Bucillamine 100 mg three times a day (“TID”), Bucillamine 200 mg TID or placebo TID for up to 14 days; the primary objective is to compare the frequency of hospitalization or death in patients with mild-moderate COVID-19 receiving Bucillamine therapy with those receiving placebo; the primary endpoint is the proportion of patients meeting a composite endpoint of hospitalization or death from the time of the first dose through Day 28 following randomization.
As such, since Chianelli teaches administering bucillamine during an infection to treat COVID 19 symptoms, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to treat a subject suffering from COVID 19 having persistent viral infection in the airways and lungs, since the art teaches that bucillamine is useful for treating COVID 19 symptoms during infection.
Regarding claim 33, It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to administer bucillamine to the subject as soon as symptoms of COVID 19 infections were detected since the skilled artisan would have wanted to mitigate symptoms for the comfort of the patient.
Taken together, all this would result in the practice of the method of claims 31 and 33 with a reasonable expectation of success.
Claims 35 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Chianelli et al (WO 2021/184115 A1, effective filing date March 19, 2020) as applied to claims 30, 32, 34, 36-41, 43-45, 48, and 49 above, and further in view of Biswal et al (US 2013/0039928 A1).
Chianelli teaches all the limitations of claims 35 and 42 (see above 102 rejection), except wherein bucillamine is administered by pulmonary delivery.
However, Biswal teaches a method comprising administering an agent that increases Nrf2 biological activity in the cell (claim 1); wherein the agent is listed in Table 1 (claim 5); a method for treating a pulmonary infection in a subject comprising administering an effective amount of an agent that increases Nrf2 biological activity (claim 42); and a device for dispersing an effective amount of an agent that increases a Nrf2 biological activity into particles and delivering a dose of said particles to lung tissue of a subject (claim 53). Biswal teaches an agent that increases Nrf2 biological activity is bucillamine (Table 1). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to administer bucillamine by pulmonary delivery since the prior art establishes that devices for dispersing an effective amount of an agent that increases Nrf2 biological activity including bucillamine and delivering said particles to lung tissue of a subject was known in the art and that this route of administration was useful for treating pulmonary infections.
Taken together, all this would result in the practice of the method of claims 35 and 42 with a reasonable expectation of success.
Conclusion
Claims 30-45, 48, and 49 are rejected.
No claim is allowed.
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/Rayna Rodriguez/ Primary Examiner, Art Unit 1628